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  • Month: February 2020

    • Join Top Genomics and Regulatory Experts to Analyze the Law Governing Genomics Research, Data, and Clinical CareFebruary 25th, 2020

      Genetics and genomics are becoming crucial to clinical care. As the “precision medicine” revolution spreads, cancer treatment, rare disease diagnosis, and cardiac care increasingly utilize genomics. Unfortunately, law and policy lag behind science, and the law governing genomics remains unclear – which means the time …

    • Vanda Isn’t Dropping This Bone Despite Negative Court DecisionFebruary 21st, 2020

      Blog readers may be thinking, “HPM, didn’t you just blog about the Vanda case last week?”  We certainly did (and had previously here and here).  You will recall that Vanda Pharmaceuticals did not prevail in its quest to have the Court find that FDA’s imposition …

    • FTC Seeks Public Comment on its Endorsement GuidesFebruary 20th, 2020

      At a time when some influencers are making good money – and sometimes millions of dollars – for endorsing and promoting everything from fake eyelashes on Instagram to the latest video game on YouTube, the Federal Trade Commission (FTC) announced on February 12, 2020 that …

    • FDA Releases Final Installment of FSMA Intentional Adulteration Guidance; Inspections Start (Gulp) Next MonthFebruary 19th, 2020

      On February 13, the FDA released the final installment of guidance to support compliance with the Intentional Adulteration (IA) Rule under the FDA Food Safety Modernization Act (FSMA). The FSMA final rule on intentional adulteration, entitled “Mitigation Strategies to Protect Food against Intentional Adulteration” (IA …

    • Paw Shucks: Court Defers to FDA’s Request for Additional Animal StudiesFebruary 18th, 2020

      Animals, shmanimals.  Or so says FDA.  Well, FDA didn’t actually say that, but that’s the effect of the District Court of D.C.’s recent ruling in Vanda Pharmaceuticals v. FDA.  In a case we have been following for the last year or so, the District Court …

    • Petition Requesting that FSIS Declare Thirty-One Salmonella Serotypes Adulterants in Meat and PoultryFebruary 17th, 2020

      On January 24, 2020, the Food Safety Inspection Service (FSIS) announced that it had received a Petition by Marler Clark LLP, on behalf of several individuals (victims of food poisoning from Salmonella containing meat or poultry products) and three consumer advocacy organizations (Food & Water …

    • Does Your Unapproved Device, Drug or Biologic Qualify for an Emergency Use Authorization (EUA)?February 14th, 2020

      The FDA is taking very seriously the threat of the coronavirus from China (2019‑nCoV).  Makers of medical devices, drugs and biologics should consider whether their products can contribute to countering this threat. In late January, FDA announced its strategy to advance development of medical countermeasures to …

    • Acetris Case – Federal Circuit Rules that a Drug Tableted in the U.S. is Manufactured in the U.S. and Eligible for Government ProcurementFebruary 14th, 2020

      On February 10, the Court of Appeals for the Federal Circuit ruled that the Department of Veterans Affairs (“VA”) erred in interpreting the Trade Agreements Act of 1979 (“TAA”) and the Federal Acquisition Regulation (“FAR”) to exclude from procurement pharmaceutical products that are manufactured in …

    • Yesterday’s FTC Announcement: Reminder of Broad Commission Authority; Portent of Things to Come for FDA Regulated Companies?February 13th, 2020

      Yesterday’s announcement by the U.S. Federal Trade Commission (“FTC”) that it was issuing so-called “6(b) Orders” to heavyweights in the tech industry at first glance, might not seem relevant to most readers of the blog, but it is.   As the announcement reminds us, “Section 6(b) …

    • HP&M is Pleased to Welcome Karin Moore to the Firm as a DirectorFebruary 12th, 2020

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Karin Moore has become its newest Director.  Drawing on her years of experience as a former general counsel to leading trade associations, Karin is an industry expert and thought leader in the areas of …

    • Richard Lewis Joins HP&M as Senior Regulatory Device & Biologics ExpertFebruary 12th, 2020

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Richard Lewis has become its newest Senior Regulatory Device & Biologics Expert.   Coming to us after more than 4 years at FDA, Richard worked in the Center for Biologics Evaluation and Research (CBER) and …

    • Knives Out: Carving Up an aBLAFebruary 12th, 2020

      As more biosimilars are approved (we’re up to 26 now!), FDA has been rolling out guidance documents under the Biosimilars Action Plan (“BAP”).  The most recent guidance has been long awaited.  While the Hatch-Waxman Act explicitly provides that an applicant can seek approval for only …

    • The Value of Priority Review Vouchers – GAO’s Two CentsFebruary 11th, 2020

      Congress enacted several priority review voucher (“PRV”) programs in the past fifteen or so years with the goal of incentivizing drug companies to develop new drugs for diseases that ordinarily may not be attractive because the potential market is small or otherwise unlikely to produce …

    • FDA Law Alert – February 2020February 10th, 2020

      Hyman, Phelps & McNamara, P.C. is pleased to publish the first FDA Law Alert of the new year. This is the fourth installment of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to …

    • Dueling It Out with FDA over NCE ExclusivityFebruary 7th, 2020

      Those familiar with the Hatch-Waxman Act and its various incentives to stimulate drug innovation know that New Chemical Entity (“NCE”) exclusivity is the holy grail of small molecule exclusivity.  Though orphan drug may give a sponsor two more years of exclusivity than NCE, it only …